Biopsy sampling method and device for the female genital tract

ABSTRACT

The device comprises an elongated tubular sheath which is adapted to be inserted into the vagina of a patient, and the distal end portion of which is adapted to engage the cervix of the patient to locate the sheath in the vagina. An aspirator pipette is slidably engaged in the sheath, to be extended from the sheath into the endocervical canal and/or the uterine cavity of the patient, or alternately to be retracted into the sheath from the canal, while the sheath is engaged with the cervix. In addition, there are means whereby after the pipette has been retracted into the sheath, a specimen can be discharged from the same onto a repository for the specimen, as well as means whereby the sheath can be maintained in the vagina while the specimen is discharged onto the repository.

[ BIOPSY SAMPLING METHOD AND DEVICE FOR THE FEMALE GENITAL TRACT Gerald C. Kohl, Tacoma, Wash.

[73] Assignee: Medics Research & Development,

Inc., Spokane, Wash.

22 Filed: Aug. 7, 1972 21 Appl. No.: 278,608

[75] I Inventor:

[52] U.S. Cl. 128/2 B, 128/2 M, 128/304, 128/348 [51] Int. Cl A6lb 10/00 [58] Field of Search 128/2 B, 2 R, 2 F, 2 M, 128/2 W, 278, 276, 304, 348

[56] References Cited UNlTED STATES PATENTS 2,482,622 9/1949 Kahn 128/348 3,320,948 5/1967 Martin 128/348 X 3,554,185 1/1971 Kohl 128/2 B 3,670,732 6/1972 Robinson 128/304 X 2,707,957 5/1955 Sollmann 128/348 3,088,454 5/1963 Shute 128/2 B 3,503,385 Stevens 128/2 M [451 Mar. 12, 1974 Oster 128/2 B MacLean 128/2 B Primary Examiner--Kyle L. Howell Attorney, Agent, or Firm-Christensen, OConnor, Garrison & Havelka ABSCT The device comprises an elongated tubular sheath which is adapted to be inserted into the vagina of a pacervix. In addition, there are means whereby after the pipette has been retracted into the sheath, a specimen can be discharged from the same onto a repository for the specimen, as well as means whereby the sheath can be maintained in the vagina while the specimen is discharged onto the repository.

20 Claims, 11 Drawing Figures BIOPSY SAMPLING METHOD AND DEVICE FOR THE FEMALE GENITAL AGT SUMMARY OF THE INVENTION This invention relates to a biopsy sampling device, and more particularly to a biopsy sampling device of the type disclosed in my U. S. Pat. No. 3,554,185, issued Jan. 12, 1971. Relative to the patented device, however, the present device is greatly improved, in that it is capable of sampling the whole of the female genital tract, including the uterine cavity, and if desired, can be employed to sample a plurality of angularly spaced points on the perimeter of the cavity, even while the device remains in the vagina of the patient. Also, if desired, the device can be secured to the patient, while in position in her vagina, by interengaging it with a tenaculum or the like which is engaged in turn, for example, with the cervix of the patient.

According to the invention, 1 am able to realize these objects and advantages from a device that comprises an elongated tubular sheath which is adapted to be inserted into the vagina of the patient, and the distal end portion of which is adapted to engage the cervix of the patient to locate the sheath in the vagina. An aspirator pipette is slidably engaged in the sheath, to be extended from the sheath into the endocervical canal and/or the uterine cavity of the patient, or alternately to be retracted into the sheath from the canal, while the sheath is engaged with the cervix. In addition, there are means whereby after the pipette has been retracted into the sheath, a specimen can be discharged from the same onto a repository for the specimen; as well as means whereby the sheath can be maintained in the vagina while the specimen is discharged onto the repository.

As indicated, the device may also include means for sampling a plurality of angularly spaced points on the perimeter of the cavity. For example, the pipette may be rotatable in relation to the sheath, and may have means thereon whereby the distal end portion of the pipette is engageable with different points on the perimeter of the cavity when the pipette is successively retracted, rotated, and extended once again into the cavity. In certain of the presently preferred embodiments of the invention, for example, the distal end portion of the pipette is normally curvilinear in configuration, but is also sufficiently resiliently flexible that the pipette can be retracted into the sheath from the canal, and then rotated to another angular position in the sheath, at which the distal end portion of the pipette will engage another point on the perimeter of the cavity, when the pipette is reextended into the canal.

To assist in the sampling operation, moreover, the pipette and the sheath may have cooperatively engageable means thereon for indexing the pipette to the sheath at relatively angularly offset positions corresponding to the points on the perimeter of the cavity. For example, the pipette as a whole may be retractable from the proximal end of the sheath, and may have means thereon whereby it is re-engageable with the sheath at relatively angularly offset positions corresponding to the points on the perimeter of the cavity. In the presently preferred embodiments of the invention, for example, the pipette and the sheath include relatively inner and outer telescopically engageable barrels which have polygonal cross sections of three equally dimensioned sides or greater, so that the pipette can be indexed to the sheath at each angular position of one within the other.

Preferably the distal end portion of the sheath takes the form of a spatulated sampling tip of the type disclosed in my aforementioned patent; and the barrel of the sheath is interconnected with the tip by a flexible sleeve of the type also disclosed in my patent. In the present device, however, the pipette is slidably engaged in the tip, and preferably takes the form of a plastic tube which resumes a curvature imparted to it, after it is temporarily flexed into a more rectilinear condition while undergoing passage through the sheath. The proximal end portion of the tube is secured within the barrel of the pipette, and is equipped with means on the proximal end thereof for attaching an aspirator thereto. The pipette also has a stop thereon, for limiting the extent to which the tube is extended beyond the sampling tip, and preferably the stop takes the form of a flange on the proximal end of the barrel of the pipette.

As indicated, the device may also include means for interengaging the sheath with a tenaculum or the like which is engaged in turn with the cervix of the patient. At present, this latter means takes the form of a collar which is slidably engaged on the barrel of the sheath, and has an ear outstanding thereon which is interengageable with the tenaculum in the closed position thereof. The car may be interengageable with the ratchet of the tenaculum, as for example, where the ear has an aperture therein within which the ratchet is engageable in the closed position of the tenaculum; or the ear may be interengageable with the tenaculum otherwise, as for example, where the collar has a pair of grooved ears thereon, the grooves of which are interengageable with the arms of the tenaculum in the closed position thereof.

BRIEF DESCRIPTION OF THE DRAWINGS These features will be better understood by reference to the accompanying drawings which illustrate certain of the preferred embodiments.

In the drawings,

FIG. l is an elevational view of the device;

FIG. 2 is a longitudinal cross-sectional, part schematic view of the device;

FIG. 3 is an exploded perspective view of the device;

FIG. 4 is a schematic view of the device at the time of use;

FIG. 5 is another such view of the device;

FIG. 6 is a greatly enlarged plan view of the usage, illustrating one aspect thereof;

FIG. 7 is a part perspective view of the device, illustrating another aspect of the usage;

FIG. 8 is an end elevational view of the device, elaborating on the aspect illustrated in FIG. 7;

FIG. 9 is a cross-sectional view of the device as it is used in FIG. 6;

FIG. 10 is a plan view illustrating a modified version of the device as it would be used in FIG. 6; and

FIG. 1 1 is a cross-sectional of the modified version at the time of use.

DESCRIPTION OF THE PREFERRED EMBODIMENTS.

Referring to the drawings, it will be seen that the device 2 comprises and elongated tubular sheath 4 which is adapted to be inserted into the vagina 6 of a patient, and has a spatulated sampling tip 8 of the type mentioned, at the distal end thereof, that is adapted to engage the cervix of the patient to locate the sheath in the vagina. The device also comprises an aspirator tube or pipette 12 which is slidably engaged in the sheath, to be extended from the tip 3 into the endocervical canal 14 and/or uterine cavity 16 of the patient, or alternately to be retracted into sheath 4 from the canal, while the tip 3 is engaged with the cervix MI. The pipette I2 is also removable from the sheath at the proximal end 18 thereof, so that a specimen can be discharged from the same onto a repository (not shown) separate from the sheath, as shall be explained.

Referring to FIGS. ll 3 in particular, it will be seen that the sheath 4 takes the form of an elongated barrel 20 of square cross section which is interconnected with the tip 8 by a flexible sleeve 22 of the type mentioned. The sleeve 22 has a spiral wound groove 24 therein which provides a corrugated effect whereby the sleeve is capable of flexing both axially and transversely of the barrel. In addition, the sleeve has a plain cylindrical neck 26 at either end thereof, and the barrel and the tip have cylindrical nipples 28 and 30 on the adjacent ends thereof, over which the necks of the sleeve are engaged and bonded to the respective components. Otherwise, the tip 8 comprises a flat, generally heart-shaped spatula 32, the relatively forward edge of which has a pointed nose 34 projecting from the center portion thereof, which in turn has smoothly filleted indentations 36 in the upper and lower sides thereof. The nose 34 is blunt at the forward end thereof, however, and contains an opening 38 for a smooth cylindrical bore 40 which extends forwardly from the nipple 30 through the spatula 32 and the nose 34. The nipple 28 of the barrel 20 also has a smooth cylindrical bore 42 therethrough, which is smoothly countersunk at the rear end thereof, however, to provide a flared opening 44 for receiving the pipette when it is reinserted in the sheath, as shall be explained.

The pipette 12 takes the form of an elongated barrel 46 of square cross section which is telescopically engageable in the barrel 20 of the sheath, and has a flexible plastic tube 48 with a memory capability, secured therein. The tube projects forwardly from the distal end 50 of the barrel, but terminates at the proximal end 51 of the same, where it is bonded within the bore of a flanged coupling 52 that is secured to the latter end of the barrel. The coupling 52 is threaded for attachment to an aspirator (not shown), and has a knurled surface 54 on the perimeter thereof, for ease in gripping the pipette.

In use, the sheath is inserted in the vagina 6 of the patient, and the tip 8 is abutted against the portio vaginalis of the cervix, with the nose 34 of the same protruding into the endocervical canal 114. Thereafter, the pipette I2 is introduced into the sheath, with the tube 48 of the same, bent and oriented so that it will curve upwardly within the uterine cavity 16, when it recovers its normal curvature after passing through the sheath and the canal. See FIGS. 6 8. A specimen is then withdrawn into the pipette, and the pipette in turn is Withdrawn from the sheath, to enable the specimen to be discharged onto the repository for the same. Meanwhile, the sheath is left in the vagina. The pipette is then returned to the sheath, but at a different position, such as the three oclock position of FIGS. 6 8, in which it is curved to the right in a horizontal plane. The specimen and pipette are then withdrawn as before,

and after the additional specimen is discharged, the pipette is returned to the sheath, and to the cavity, at still another position, such as the six oclock position." Ultimately, all four quadrants of the cavity are sampled in this fashion, and if desired, the device may also be employed to sample the endocervical canal, and/or the portio vaginalis, as in the case of my earlier device. Moreover, as illustrated in FIGSA and 5, this is possible whether the uterus is aligned with the vagina, or askew from it, as in FIG. 5.

Each time the pipette is returned to the sheath, the fact of abutting the flange 56 of the coupling 52 against the proximal end 18 of the sheath, reveals that the tip of the curved memoried tip of the tube 48 is in position in the cavity, and that another sample can be immediately taken. Moreover, as the sample is withdrawn, it is fully enclosed in the sheath, and since the sheath is sterile, it protects the sample from contamintion, during the passage of the sample through the vagina.

A speculum (not shown) is normally employed to dilate the vaginal canal. As seen, moreover, the sheath is equipped with means whereby the device can be secured to the patient in her vagina during the sampling operation. Referring to FIGS. 6 111, it will be seen that the barrel 20 of the sheath has a clip 58 mounted thereon, which can be cooperatively engaged with a tenaculum 60, after the tenaculum is also inserted in the vagina of the patient. In FIGS. 6 and 9, the clip comprises a split G-shaped collar 62 which is slidably engageable on the barrel 20, and has a ring-shaped ear 64 outstanding thereon, through which the ratchet members 66 of the tenaculum may be engaged with one another, to fix the position of the sheath, and incidentally, the position of the tenaculum as well. The members 66 are engaged when the pincers 68 of the tenaculum are in position to engage the flesh of the cervix, and when the collar 62 is in position to receive them, there being sufficient frictional engagement between the collar 62 and the barrel 20 to maintain the arrangement which results. See FIG. 6.

In FIGS. MI and ll, the tenaculum is also employed to tighten the grip of the clip 58 on the barrel. In this instance, the clip 58' also has a G-shaped collar 70, but there is a pair of ears 72 on the collar at the split side thereof, and each of the ears has a notch or groove 74 adjacent the free end thereof to receive one arm 76 of the tenaculum. In use, the ears 72 are interposed between the arms 76 of the tenaculum, and the arms are engaged in the grooves '74 as they are ratcheted together to grip the cervix between the pincers of the tenaculum. The clamping action on the ears, in turn clamps the collar more firmly about the barrel, so as to assure that the collar remains stationary on the barrel in the position assigned to it. Otherwise, however, the collar may be moved along the length of the barrel to position it in relation to the tenaculum.

What I claim is:

l. A device for collecting biopsy specimens from the female genital tract comprising an elongated tubular sheath which is adapted to be inserted in the vagina and has an open-ended nose at the distal end thereof adapted for insertion in the cervix, said sheath being adapted in length to extend outside of the vagina when the nose is so inserted, and having an open-ended aspirator tube reciprocably engaged therein, said tube having means thereon whereby it can be reciprocated from a point outside of the vagina, and the distal end portion of said tube being adapted to be extended forwardly through and beyond the open end of the nose into the uterine cavity, and alternately retracted into the sheath from the cavity, there being means on the proximal end portion of the tube whereby suction can be generated therein while the distal end portion thereof is so extended, and said distal end portion of the tube being flexible, but having a memoried curve therein, whereby the distal end of the tube deflects toward the wall of the cavity when said portion is extended thereinto, yet said portion is accommodatable within the sheath when it is retracted therein, and the opening in said distal end of the tube being in substantial coincidence with the distal end of the curve so that points on the periphery of the cavity can be sampled by applying suction to the tube while the distal end thereof is deflected toward the wall of the cavity.

2. The device according to claim 1 wherein the distal end portion of the tube is slidably guided in the nose of the sheath.

3. The device according to claim 2 wherein the sheath is substantially circumferentially closed along the length thereof between the nose and a point on the sheath outside of the vagina.

4. The device according to claim 1 wherein the distal end portion of the tube is rotatable with respect to the sheath.

5. The device according to claim 4 wherein there are means operatively interposed between the tube and the sheath whereby the distal end portion of the tube can be indexed to the sheath in a plurality of relatively angularly offset orientations therein.

6. The device according to claim 5 wherein the tube and sheath include telescopically engageable barrels which are polygonal in cross section, and the tube is retractably inserted in the sheath so that the tube can be reoriented by retracting it from the sheath and rotating it to each new orientation before it is reinserted in the sheath.

7. The device according to claim 5 further comprising means on the sheath whereby the sheath can be secured to the patient to fix the orientation thereof, by operatively interconnecting a tenaculum therebetween.

8. The device according to claim 4 further comprising means on the sheath whereby the sheath can be secured to thepatient to fix the orientation thereof, by operatively interconnecting a tenaculum therebetween.

9. The device according to claim 8 wherein the sheath has a clip slidably engaged thereon which is equipped with clamping means that are interengageable between the arms of the tenaculum to clamp the clip to the sheath in a fixed position thereon.

10. The device according to claim 1 wherein the tube has a length greater than that of the sheath so that it can be reciprocated by manipulating the proximal end portion of the same.

11. The device according to claim 1 wherein the distal end portion of the sheath has locator means thereon which are adapted to abut the portio vaginalis when the nose is inserted in the cervix.

H2. The device according to claim 11 wherein the length of the nose of the sheath is adapted so that the nose terminates in the endocervical canal at a point short of the uterine cavity, when the locator means is abutted against the portio vaginalis.

13. The device according to claim 11 wherein the locator means take the form of a spatulated sampling tip.

14. The device according to claim 13 wherein the proximal end portion of the sheath takes the form of an elongated barrel which is interconnected with the tip by a flexible sleeve.

15. The device according to claim ll wherein the tube has stop means thereon for limiting the extent to which the distal end portion thereof is extendible beyond the open end of the nose.

16. A method of collecting biopsy specimens from the female genital tract, comprising inserting into the cervix of the patient, the open-ended nose of an elongated tubular sheath which is adapted in length to extend outside of the vagina of the patient when the nose is so inserted, inserting the open-ended, memoried, flexibly curved tip of an aspirator tube into the nose of the sheath and extending the tip forwardly beyond the open end of the nose into the uterine cavity of the patient, and sampling a plurality of angularly offset points about the periphery of the cavity by applying suction to the tube, retracting the tip of the tube into the sheath, discharging the sample from the tube onto a repository for the same, and rotating and reextending the tip of the tube into the cavity so that on reassuming the curve thereof, the tip deflects toward the next point to be sampled therein.

17. The method according to claim 16 wherein the distal end portion of the sheath has locator means thereon, and the locator means is abutted with the portio vaginalis of the patient when the nose is inserted in the cervix.

18. The method according to claim 17 wherein the locator means takes the form of a spatulated sampling tip, and the sheath is rotated to sample the portio vaginalis.

19. The method according to claim 17 wherein the nose of the sheath is adapted to terminate in the endocervical canal at a point short of the uterine cavity, when the locator means is abutted against the portio vaginalis, and suction is also applied to the tube when the open end of the tip is disposed in the canal.

20. The method according to claim 16 further comprising securing the sheath to the patient so as to fix the orientation of the sheath while the tip of the tube is rotated with respect to the same.

=l =l a 

1. A device for collecting biopsy specimens from the female genital tract comprising an elongated tubular sheath which is adapted to be inserted in the vagina and has an open-ended nose at the distal end thereof adapted for insertion in the cervix, said sheath being adapted in length to extend outside of the vagina when the nose is so inserted, and having an open-ended aspirator tube reciprocably engaged therein, said tube having means thereon whereby it can be reciprocated from a point outside of the vagina, and the distal end portion of said tube being adapted to be extended forwardly through and beyond the open end of the nose into the uterine cavity, and alternately retracted into the sheath from the cavity, there being means on the proximal end portion of the tube whereby suction can be generated therein while the distal end portion thereof is so extended, and said distal end portion of the tube being flexible, but having a memoried curve therein, whereby the distal end of the tube deflects toward the wall of the cavity when said portion is extended thereinto, yet said portion is accommodatable within the sheath when it is retracted therein, and the opening in said distal end of the tube being in substantIal coincidence with the distal end of the curve so that points on the periphery of the cavity can be sampled by applying suction to the tube while the distal end thereof is deflected toward the wall of the cavity.
 2. The device according to claim 1 wherein the distal end portion of the tube is slidably guided in the nose of the sheath.
 3. The device according to claim 2 wherein the sheath is substantially circumferentially closed along the length thereof between the nose and a point on the sheath outside of the vagina.
 4. The device according to claim 1 wherein the distal end portion of the tube is rotatable with respect to the sheath.
 5. The device according to claim 4 wherein there are means operatively interposed between the tube and the sheath whereby the distal end portion of the tube can be indexed to the sheath in a plurality of relatively angularly offset orientations therein.
 6. The device according to claim 5 wherein the tube and sheath include telescopically engageable barrels which are polygonal in cross section, and the tube is retractably inserted in the sheath so that the tube can be reoriented by retracting it from the sheath and rotating it to each new orientation before it is reinserted in the sheath.
 7. The device according to claim 5 further comprising means on the sheath whereby the sheath can be secured to the patient to fix the orientation thereof, by operatively interconnecting a tenaculum therebetween.
 8. The device according to claim 4 further comprising means on the sheath whereby the sheath can be secured to the patient to fix the orientation thereof, by operatively interconnecting a tenaculum therebetween.
 9. The device according to claim 8 wherein the sheath has a clip slidably engaged thereon which is equipped with clamping means that are interengageable between the arms of the tenaculum to clamp the clip to the sheath in a fixed position thereon.
 10. The device according to claim 1 wherein the tube has a length greater than that of the sheath so that it can be reciprocated by manipulating the proximal end portion of the same.
 11. The device according to claim 1 wherein the distal end portion of the sheath has locator means thereon which are adapted to abut the portio vaginalis when the nose is inserted in the cervix.
 12. The device according to claim 11 wherein the length of the nose of the sheath is adapted so that the nose terminates in the endocervical canal at a point short of the uterine cavity, when the locator means is abutted against the portio vaginalis.
 13. The device according to claim 11 wherein the locator means take the form of a spatulated sampling tip.
 14. The device according to claim 13 wherein the proximal end portion of the sheath takes the form of an elongated barrel which is interconnected with the tip by a flexible sleeve.
 15. The device according to claim 1 wherein the tube has stop means thereon for limiting the extent to which the distal end portion thereof is extendible beyond the open end of the nose.
 16. A method of collecting biopsy specimens from the female genital tract, comprising inserting into the cervix of the patient, the open-ended nose of an elongated tubular sheath which is adapted in length to extend outside of the vagina of the patient when the nose is so inserted, inserting the open-ended, memoried, flexibly curved tip of an aspirator tube into the nose of the sheath and extending the tip forwardly beyond the open end of the nose into the uterine cavity of the patient, and sampling a plurality of angularly offset points about the periphery of the cavity by applying suction to the tube, retracting the tip of the tube into the sheath, discharging the sample from the tube onto a repository for the same, and rotating and reextending the tip of the tube into the cavity so that on reassuming the curve thereof, the tip deflects toward the next point to be sampled therein.
 17. The method according to claim 16 wherein the distal end portion of the sheath has locator meAns thereon, and the locator means is abutted with the portio vaginalis of the patient when the nose is inserted in the cervix.
 18. The method according to claim 17 wherein the locator means takes the form of a spatulated sampling tip, and the sheath is rotated to sample the portio vaginalis.
 19. The method according to claim 17 wherein the nose of the sheath is adapted to terminate in the endocervical canal at a point short of the uterine cavity, when the locator means is abutted against the portio vaginalis, and suction is also applied to the tube when the open end of the tip is disposed in the canal.
 20. The method according to claim 16 further comprising securing the sheath to the patient so as to fix the orientation of the sheath while the tip of the tube is rotated with respect to the same. 